Advancing Research to Understand Congenital Malformations (R01 Clinical Trial Not Allowed)

The NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has announced the funding opportunity "Advancing Research to Understand Congenital Malformations" (PAR-25-146) to support research focused on uncovering the mechanisms behind structural birth defects. This R01 grant encourages proposals that combine animal models with translational or clinical approaches to explore genetic, epigenetic, and environmental factors contributing to structural birth defects, using innovative methods like genetics, omics, synthetic biology, and biochemical approaches. This opportunity emphasizes understanding gene-environment interactions that affect the susceptibility and variability of structural birth defects in human populations, with the long-term goal of developing preventive, diagnostic, and therapeutic strategies. NICHD encourages interdisciplinary collaboration among clinicians, geneticists, epidemiologists, and basic scientists, though collaboration is not mandatory. Projects might include research on the genetic and environmental determinants of congenital anomalies across multiple systems (e.g., cardiac, craniofacial, musculoskeletal), excluding syndromic and neurodevelopmental conditions unless focused on structural aspects. NICHD specifically excludes studies limited to traditional epidemiology or those that do not address the biological factors of structural birth defects. The scope of research may include identifying genetic polymorphisms associated with birth defects, studying gene regulatory networks, examining gene-environment interactions, and developing biomarkers for exposure and susceptibility. Projects are encouraged to utilize publicly available datasets from sources like the National Birth Defects Prevention Study (NBDPS) and the Gabriella Miller Kids First Pediatric Research Program. NICHD expects data sharing through its Data and Specimen Hub (DASH) and encourages deposit of biospecimens and human genetic data through repositories like dbGaP. The grant allows for budgets of up to $499,999 in direct costs annually, with a maximum project period of five years. Eligible applicants include higher education institutions, nonprofits, for-profit entities, and foreign organizations, among others. Institutions must be registered with NIH eRA Commons, SAM, and Grants.gov before applying. Applications must be compliant with NIH’s latest data-sharing policies, including submitting a data management and sharing plan as part of the proposal. Evaluation criteria include significance, innovation, approach rigor, and the research environment. Proposals will be reviewed for scientific merit, alignment with NICHD priorities, and feasibility. Notably, applications should address the sharing of data and biospecimens, as NICHD prioritizes the dissemination of findings to the broader research community. Applications are due on NIH’s standard due dates starting February 5, 2025, and the funding opportunity will expire on September 8, 2025. For further assistance, applicants can contact the NICHD’s scientific or grants management officials.